NCT04368702

CONFIRM: Magnetic Resonance Guided Radiation Therapy

Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Detailed description

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer. In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located. The research study procedures include: * Screening for eligibility * Study treatment including evaluations * Follow up visits * Questionnaires This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation. The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Conditions

• Gastric Cancer
• Invasive Breast Cancer
• in Situ Breast Cancer
• Mantle Cell Lymphoma
• Larynx Cancer
• Bladder Cancer

Interventions

Type	Name	Description
RADIATION	Viewray MRIdian® Linac	MR-image guided radiation will be administered per disease site standards.

Timeline

• Start date: 2021-05-01
• Primary completion: 2029-06-18
• Completion: 2029-06-18
• First posted: 2020-04-30
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study